Shandra Eisenga Human Cell and Tissue Product Safety Act
- Sponsor
- Sen. Peters, Gary C. [D-MI]
- Committees
- Health, Education, Labor, and Pensions Committee (primary)
- Last action
- Jun 24, 2026
Bottom line
The bill seeks to improve public and professional awareness, strengthen enforcement, and modernize regulatory processes for human cell and tissue products to enhance patient safety and regulatory predictability.
What it actually does
This bill, named the Shandra Eisenga Human Cell and Tissue Product Safety Act, aims to enhance the safety and oversight of human cell and tissue products (HCT/Ps). It mandates a public awareness campaign for healthcare professionals on organ, tissue, and eye donation, including screening tests. Crucially, it establishes civil penalties for violations of HCT/P regulations and requires the FDA to increase transparency and streamline regulatory oversight through public information, educational initiatives, and a report to Congress on modernizing HCT/P regulation.
Proponents argue
Supporters argue that this bill is a critical step to protect public health by ensuring greater transparency and accountability in the human cell and tissue product industry. They contend that increased awareness among healthcare providers and the public, coupled with robust civil penalties for non-compliance, will reduce risks associated with these transplants. Furthermore, streamlining FDA's regulatory processes and providing clear guidance will foster scientific advancement while maintaining safety standards.
Opponents contend
Critics might argue that while the intent is good, the new civil penalties could disproportionately burden smaller tissue establishments or lead to overly cautious practices that hinder access to potentially life-saving therapies. Some may also express concern that increased regulatory scrutiny and reporting requirements, even if intended to streamline, could inadvertently create additional administrative burdens without a clear, proportional benefit to public health, potentially stifling innovation.
The bill is concise and can be read and understood by an informed reader within a short timeframe, making it accessible for evaluation.
Section 3
Human Cell and Tissue Products Transplant Public Awareness Campaign
This section directs the Secretary of Health and Human Services to develop and distribute educational materials. These materials are intended for healthcare professionals and others involved in organ, tissue, and eye donation. The goal is to inform them about evidence-based methods for approaching patients and families regarding donation, the availability of donor screening tests, and other important aspects of the donation process.
Supporters argue
Supporters argue that an informed healthcare community is vital for ensuring safe and ethical donation practices and for increasing the availability of needed tissues and organs. This campaign will standardize best practices and ensure critical information, like donor screening tests, is widely understood.
Critics contend
No specific opposition is typically raised against public awareness campaigns aimed at improving healthcare professional knowledge, as they are generally seen as beneficial for public health and safety.
Tradeoffs
The primary tension might be resource allocation, ensuring sufficient funding and effective distribution channels for the educational materials without diverting resources from other critical public health initiatives.
Section 4
Civil Penalties for Violation of Requirements for Human Cell and Tissue Products
This section amends the Public Health Service Act to introduce significant civil penalties for individuals or entities that violate specific FDA regulations (subpart C or D of 21 CFR 1271) concerning human cell and tissue products. Violators could face a penalty of $20,000 per violation, with an additional $20,000 for each day a violation continues after written notice. Furthermore, an amount equal to the retail value of the products involved in the violation can be added, with a total cap of $10,000,000 per proceeding.
Section 5
Streamlining Regulatory Oversight of Human Cell and Tissue Products
This section mandates several actions by the FDA to improve transparency and efficiency in regulating human cell and tissue products. It requires the FDA to publish educational materials and best practices for its Tissue Reference Group, annually report on HCT establishment registrations, inspections, and Tissue Reference Group inquiry statistics. It also directs the FDA to conduct workshops for stakeholders, amend existing law to update scientific guidance for cellular therapies, establish a public docket for comments on modernizing HCT/P regulation, and submit a comprehensive report to Congress with recommendations for regulatory updates by September 30, 2026.